Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease

NCT00010387 | Completed Phase 2

• 3 other identifiers: 199/15672JHOC-J9881JHOC-99012906
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVES: I. Determine the response rate and 1-year event-free survival in patients with severe autoimmune hematologic disease treated with high-dose cyclophosphamide.

Conditions

Anemia, Hemolytic, Autoimmune; Felty Syndrome; Purpura, Thrombocytopenic; Autoimmune Diseases

Keywords

Felty syndrome; autoimmune hemolytic anemia; autoimmune neutropenia; hematologic disorders; immune thrombocytopenic purpura; rare disease

Interventions

cyclophosphamide DRUG

filgrastim DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Diagnosis of severe autoimmune hematologic disease Autoimmune hemolytic anemia OR Immune thrombocytopenia * Failure of at least 2 standard treatment approaches (e.g., prednisone therapy, splenectomy, intravenous immunoglobulin, or other immunosuppressants) * Inability to taper prednisone dose to less than 10 mg/day OR Autoimmune neutropenia including the following: Felty's syndrome OR Disorders of large granular lymphocytes with recurrent infections or absolute neutrophil count less than 200/mm3 --Prior/Concurrent Therapy-- * See Disease Characteristics --Patient Characteristics-- * Age: Not specified * Performance status: Not specified * Hematopoietic: See Disease Characteristics * Hepatic: Not specified * Renal: Creatinine no greater than 2.5 mg/dL * Cardiovascular: Ejection fraction at least 40% * Pulmonary: FVC, FEV1, or DLCO at least 50% predicted Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Not preterminal or moribund

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Oncology Center

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune; Felty Syndrome; Purpura, Thrombocytopenic; Autoimmune Diseases; Hematologic Diseases; Purpura, Thrombocytopenic, Idiopathic; Rare Diseases

Interventions

Cyclophosphamide; Filgrastim

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hemic and Lymphatic Diseases; Immune System Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Purpura; Blood Coagulation Disorders; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Hemorrhagic Disorders; Disease Attributes

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Robert A. Brodsky

  Johns Hopkins University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 2, 2001
• First Posted: February 2, 2001
• Study Start: March 1, 1999
• Primary Completion: August 1, 2007
• Last Updated: September 10, 2008

Record last verified: 2008-09

Locations

US (1)